The European Union's Registration, Evaluation and Authorization of Chemicals (REACH) regulation comes into force on June 1. In general, the EU REACH regulation calls for registration of about 30,000 chemicals over a period of 11 years. REACH will impact companies importing to the European Union (EU) or manufacturing in Europe.

There are some basic differences between the new regulation and previous green legislation. First, REACH is a regulation, not a directive like RoHS and WEEE. This means REACH will be implemented in all 27 European member states on June 1, 2007 without interpretations that vary by member state.

Moreover, the REACH deadline is not an ultimatum that requires immediate elimination of substances as the RoHS directive required. Instead, it calls for paperwork — a formal filing of information about chemical substances used.

While REACH compliance seems simple, it isn't. Formed after years of battling among politicians, technocrats, industry and NGOs, REACH has emerged as a highly complex and convoluted law that is approximately 700 pages with a brief overview totaling 20 pages.

Understanding the legislation is a challenge

"The biggest challenge is to understand and follow the legislation because it's very confusing," said Anneke Vanhoorelbeke, environmental health and safety (EHS) manager for AMI Semiconductor in Belgium.

In very broad strokes, REACH obligates a manufacturer in the EU to ensure the chemicals it is using in excess of one ton annually are registered with a new central chemical agency set up in Helsinki, Finland. Registration includes supplying data such as chemical types and uses, volumes per annum and test data results.

REACH also obligates companies that import products (known as "articles") to ensure substances inside those products are registered. But it only applies if the article is designed to "intentionally release" a substance during use as in the case of a printer cartridge, for example, that is designed to discharge ink, and the substance is present in the articles at a quantity over one ton annually.

In some cases, other imported articles may obligate a company to register. But if the manufacturer proves that no one will be exposed to the substances during product use, including disposal, no registration is required.

"This becomes very complicated when talking about finished articles and a company's obligations," said Steffen Erler, technical manager for REACHReady, an online tool that helps companies determine if their substances are in the scope of REACH and estimate compliance costs. "Articles have to be defined at the substance level by tracking them through the supply chain."

The complexity of REACH means compliance is different for nearly every company, added Bruce Calder, president of Ageus Solutions Inc., (Ontario, Canada) which has introduced a REACH service that walks a company through the maze of compliance steps.

For instance, a manufacturer could be classified as a downstream user, an importer, or both. Each legal status has a different set of requirements. A company may also be split into five legal entities, each using less than one ton of a chemical per year. Or it could be under one entity, in which case the tonnage is added together and falls under the scope of REACH.

Importers don't have to be manufacturers, Calder pointed out. Mobile phones, for example, are often imported into the EU by service providers such as Vodafone that will want to ensure they are bringing in compliant product.

First steps
That said, sources agreed that 2007 is not a panic year. However, companies should begin by taking basic steps. First, identify all chemicals used in production and their annual volumes, and talk to suppliers to ensure that they are aware of their REACH responsibilities.

"Certainly some risk assessment and communication needs to start happening within the supply chain," said Mike Kirschner, president of Design Chain Associates (San Francisco, Calif.).

Upstream chemical suppliers typically don't know how their chemicals are used downstream. "They're a few levels up the chain from article manufacturers, so there are some new linkages that have to be made and new types of information that have to flow," Kirschner said.

AMI Semiconductor has already begun compliance activities in its European manufacturing operations. Vanhoorelbeke estimates AMI uses 40 to 50 different chemicals in volumes exceeding one ton per year in its European chipmaking operations. REACH won't hit AMI too hard because most chemical suppliers are European, and they are required to register, she said.

Still, AMI has work to do. EHS has to follow requirements set by the lengthy REACH legislation, which is expected to undergo some changes even at this late stage. EHS must document its inventory of chemicals and check with suppliers to see if exposure scenarios are mentioned on the chemical safety datasheets.

But more departments are involved, Vanhoorelbeke said. Production has to tell EHS exactly how the chemicals are used and in what quantities per year, and logistics has to provide data that shows suppliers have taken compliance steps.

Purchasing may also be involved. AMI said it will modify its procedure for buying chemicals from new suppliers. "We'll ensure they are REACH registered or that the supplier will be responsible for registration," she said. "It's a lot of administrative work."

AMI is preparing now for the first REACH obligation called "pre-registration", which will take place from June 1, 2008 to November 30, 2008. Pre-registration involves providing general information such as type and volume of substances and availability of animal test results to the Helsinki-based central registry.

Companies that pre-register have benefits. They can continue to use substances and take advantage of the phased registration process, which is more comprehensive and includes things like detailed technical dossiers. Registration is on a 3-, 6- and 11-year timeline.

REACH involves collaboration

The EU is pushing companies to work together in consortia for registration. Known as the "one substance, one registration" principle, it requires companies to jointly submit data on similar substances. The idea is to find data gaps, prevent duplication and lower costs.

Industry sources said they cannot yet estimate compliance costs. But some are concerned about costs associated with potential changes to critical, specialized substances. Sometime next year, the EU is expected to release a "Candidate List" of substances of "Very High Concern," which has also been referred to as a black list.

Identified substances could be restricted, making a supplier modify his chemical formula, and in turn, forcing the downstream user to requalify new processes. "Then the cost really starts to add up," said Johan Heyman, AMI's VP of European Operations, citing photoresist chemicals used in semiconductor production. "Today we don't see it, but we have to start looking at these areas."

Printed-circuit-board (PCB) manufacturers and companies with galvanic processes require specialized chemicals in small amounts, added Christian Pophal, head of corporate environmental affairs and safety at Infineon AG (Munich, Germany).

"It's essential for them to start with an internal evaluation," Pophal said. "Discuss with suppliers to ensure these chemicals are available after REACH is in place."

Sources agreed that the supplier data exchange that occurred with RoHS will be useful. REACH is primarily about supply chain communication — coordinating the registration process between manufacturers, importers and chemical suppliers.

REACH is still in flux. The Globally Harmonized System of Classification and Labeling of Chemicals (GHS), adopted by the United Nations, will impact REACH, and two more versions of the regulation are expected.

"REACH is still all very theoretical so it's very important to have close supplier contact," said Vanhoorelbeke.

Useful REACH links:

www.buyusa.gov/europeanunion/reach.html

www.euractiv.com/en/environment/implementing-eu-new-chemicals-law-reach/article-158747

http://europa.eu/rapid/pressReleasesAction.do?reference=MEMO/06/488&format=HTML&aged=0&language=EN&guiLanguage=fr

www.chemical.org.uk/reg_issues_reach_faq.asp